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发表于 2003-3-26 19:10
Phase II Studies
Abstract Summary
Entecavir (ETV) is a potent and selective HBV antiviral agent currently in phase III clinical development. A wide range of doses (0.01-1.0mg) was selected for 6 double blind, randomized phase II dose-ranging trials in treatment-naive and lamivudine (LAM) failure patients.
Adverse events (AE) were collected for all patients beginning with first dose, and up to 24 weeks following treatment. The most frequently reported clinical AEs, serious adverse events (SAEs) and study discontinuations were combined across trials, and presented by study drug.
A total of 409 patients were treated: 315 ETV, 86 LAM, and 8 placebo. 75 patients subsequently received ETV + LAM in a rollover trial. The majority of subjects reported mild to moderate AEs at some point during their treatment period.
The most frequently reported AEs were headache, rhinitis, fatigue, and abdominal pain, occurring with similar frequency in entecavir-, lamivudine- and placebo- groups. There were no differences among dose groups of entecavir.
SAEs were reported in 22/306 (7%) patients who received ETV, 8/86 (9%) patients who received LVD, and 3/75 patients who received combination therapy. A total of 13 patients were discontinued due to AEs in 4/6 trials: 9/306 (3%) treated with ETV, and 4/86 (5%) treated with LAM.
Conclusion: ETV appears to be well tolerated in patients treated to date. The frequency of adverse events does not appear to be different from lamivudine. Data from ongoing phase III trials with larger study populations will confirm these observations.
03/24/03
Reference
E R Schiff and others. SUMMARY OF PHASE II CLINICAL AND LABORATORY SAFETY EXPERIENCE WITH ENTECAVIR. Abstract 4392.00. Abstracts of the 38th Annual Meeting of the European Association of the Study of the Liver (EASL).
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